SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Haymine tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Chlorphenamine Maleate Ph.Eur.    10 mg

Ephedrine hydrochloride Ph.Eur.    15 mg

3    PHARMACEUTICAL FORM

Sustained release tablet

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Relief of symptoms caused by allergic conditions such as hay fever, allergic rhinitis, perennial rhinitis, urticaria etc., which are responsive to antihistamine.

4.2    Posology and method of administration

Adults, elderly and children over 12 years of age:

One or two tablets daily. One tablet should be taken in the morning on rising and a further tablet may be taken at night if required.

Children under 12 years of age:

Not recommended.

Method of administration - oral use.

4.3    Contraindications

Coronary thrombosis, hypertension, thyrotoxicosis and those on treatment with monoamine oxidase inhibitors.

4.4    Special warnings and precautions for use

Tablets should be swallowed whole and not sucked or chewed. Do not exceed the stated dose. Asthmatics should consult their doctor before using this product. May cause drowsiness, if affected do not drive or operate machinery. Avoid alcoholic drink.

4.5    Interaction with other medicinal products and other forms of interaction

Alcoholic drinks and certain other central nervous system depressants can potentiate any sedative effect.

4.6    Pregnancy and lactation

Contra-indicated.

4.7    Effects on ability to drive and use    machines

Caution should be employed when driving or operating machinery.

4.8    Undesirable effects

Although the combination of ephedrine    with the anti-histamine chlorphenamine is

intended to reduce side-effects, slight drowsiness may occur. Side effects of ephedrine are rare at the low dose employed in this preparation, however in particularly susceptible patients, effects such as giddiness, palpitations and muscular weakness may be experienced transiently.

4.9 Overdose

Treatment should include gastric lavage. In the event of convulsions sedate with intramuscular paraldehyde. Respiratory depression may necessitate mechanical ventilation. Symptomatic treatment of cardiovascular dysfunction should be given with careful patient monitoring. The physician should be aware that tablets in the intestine will continue to release the active ingredients for a period of hours.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Chlorphenamine is a potent H₁-blocking drug. It antagonises the pharmacological actions of histamine released by antigen-antibody reaction in allergic diseases, thus providing symptomatic relief. Chlorphenamine alone is less effective when pollen counts are high, allergen exposure is prolonged and nasal congestion has become prominent.

Ephedrine has mild CNS stimulant properties which counteract any drowsiness produced by chlorphenamine. In addition it produces a decongestant action on nasal mucosal surfaces relieving mucosal congestion in conditions such as hay fever and allergic rhinitis.

5.2    Pharmacokinetic properties

Chlorphenamine is readily absorbed after oral administration and may undergo enterohepatic re-circulation in man. It is eliminated with a t/ of 12-15 hours. Ephedrine is completely absorbed following oral administration and is eliminated with a t/ of 3-6 hours.

5.3    Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Hydroxypropylmethylcellulose Quinoline yellow Hardened castor oil Magnesium stearate Nipastat

6.2    Incompatibilities

None known

6.3    Shelf life

4 years

6.4    Special precautions    for storage

None

6.5    Nature and contents    of container

Strip packed in soft tempered aluminium foil laminated to polyethylene or blister packed in PVC/polyvinyl dichloride on hard tempered aluminium foil in 10's or 30's in cardboard cartons.

6.6 Special precautions for disposal

None stated.

7 MARKETING AUTHORISATION HOLDER

Chemidex Pharma Limited

Chemidex House, Egham Business Village

Crabtree Road

Egham

Surrey

TW20 8RB

United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 17736/0117

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

09/03/1978 / 09/04/2003

10 DATE OF REVISION OF THE TEXT

16/03/2008